UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016674 |
|---|---|
| Receipt number | R000019098 |
| Scientific Title | Diagnosis of Helicobacter pylori Gastritis by esophagogastroduodenoscopy (EGD) |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2020/03/05 14:26:31 |
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Basic information
Public title
Diagnosis of Helicobacter pylori Gastritis
by esophagogastroduodenoscopy (EGD)
Acronym
Diagnosis of Helicobacter pylori Gastritis
by EGD
Scientific Title
Diagnosis of Helicobacter pylori Gastritis
by esophagogastroduodenoscopy (EGD)
Scientific Title:Acronym
Diagnosis of Helicobacter pylori Gastritis
by EGD
Region
| Japan |
Condition
Condition
Helicobacter pylori Gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of diagnosis of Helicobacter pylori Gastritis by esophagogastroduodenoscopy (EGD)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the accuracy of Helicobacter pylori Gastritis by esophagogastroduodenoscopy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who were explained about the study and gave a written informed consent.
Key exclusion criteria
1. Advanced gastric cancer
2. History of gastric surgery
3. treatment of proton pump inhibitor, or histamine antagonist
4. Severe renal dysfunction
5. Pregnant women
6. Patients who were disqualified for the study by their physicians.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mototsugu |
| Middle name | |
| Last name | Kato |
Organization
Hokkaido University Hospital
Division name
Department of Endoscopy
Zip code
0608648
Address
N14,W5,Kita-ku,Sapporo,Hokkaido
TEL
011-716-1161
m-kato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Yoshii |
Organization
SAPPORO MEDICAL CENTER, NTT EC
Division name
Department of Gastroenterology
Zip code
0600061
Address
S1,W15,Chuo-ku,Sapporo,Hokkaido
TEL
011-623-7000
Homepage URL
shinji-yoshii@umin.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SAPPORO MEDICAL CENTER, NTT EC
Address
S1,W15,Chuo-ku,Sapporo,Hokkaido
Tel
0116237000
shinji-yoshii@umin.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019098
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/den.13486
Number of participants that the trial has enrolled
498
Results
Significantly higher diagnostic odds were obtained for
RAC (32.2), FGP (7.7), and red streak (4.7) in subjects with noninfection,
map-like redness (12.9) in subjects with past infection,
and diffuse redness (26.8), mucosal swelling (13.3), sticky mucus
(10.2) and enlarged fold (8.6) in subjects with current infection.
The overall diagnostic accuracy rate was 82.9% with the Kyoto
classification of gastritis.
Results date posted
| 2020 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this prospective study, 498 subjects were
recruited. Seven well-experienced endoscopists blinded to the
history of eradication therapy performed the examinations.
Participant flow
In this prospective study, 498 subjects were
recruited. Seven well-experienced endoscopists blinded to the
history of eradication therapy performed the examinations.
Adverse events
none
Outcome measures
The correlation of each of the 16 endoscopic features with
the three H. pylori infection statuses (current infection, noninfection,
past infection) was analyzed. Sensitivity, specificity,
positive predictive value (PPV), negative predictive
value (NPV), and diagnostic odds ratio (DOR)19 were
calculated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 01 | Day |
Other
Other related information
comparison of machine learning and endoscopic diagnosis
Management information
Registered date
| 2015 | Year | 03 | Month | 01 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019098
